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On Wednesday, June 8, Representative Mike Fitzpatrick announcing medical device and FDA reform bills. The Congressman from Pennsylvania has been a consistent supporter of women’s health issues, especially as pertains to dangerous medical devices. Once again, Rep. Fitzpatrick (R-PA) is headed to DC to fight, not only for those injured women, but for reforming the FDA’s medical device approval process. He is joined by Congresswoman Louise Slaughter (D-NY). The press release follows.

“MEDIA ADVISORY:
Fitzpatrick, Slaughter to Announce Package of Medical Device, FDA Reform Bills

WHO:

– Congressman Mike Fitzpatrick (PA-8)
– Congresswoman Louise Slaughter (D-NY)
– Families impacted by dangerous medical devices
– Patient safety advocates

WHAT: Reps. Fitzpatrick and Slaughter will join women and families affected by dangerous medical devices Essure and laparoscopic power morcellators to announce package of bills aimed at strengthening the FDA’s medical device review process and increasing accountability for dangerous products. Speakers will share the emotional effects of these failed devices and their fight for justice.

WHEN: Wednesday, June 8, 1pm

WHERE: House Triangle, U.S. Capitol Building

RSVP: To confirm coverage or request more information, contact Aaron Clark at aaron.clark@mail.house.gov. Fitzpatrick and individuals will be available for calls with press following the event – Please contact aaron.clark@mail.house.gov for more information.

BACKGROUND: Fitzpatrick has been the leading voice in Congress calling for medical device approval and review reform. Most recently, he has called for an Energy & Commerce Committee hearing on the FDA’s broken process.

Essure has harmed more than 25,000 women who have reported symptoms including extreme pelvic and abdominal pain, migraines, autoimmune reactions, loss of teeth and hair, and the coil damaging the uterus and other organs in the abdominal cavity. Last year, Fitzpatrick introduced the E-Free Act to remove the permanent sterilization device Essure from the market. [Emphasis added.]

Power Morcellators have been spreading an undetectable fibroid cancer throughout the body, like shrapnel, for decades – taking Stage 1 cancers immediately to Stage 4. For hundreds, if not thousands of women, what was supposed to be a routine procedure ended with a death sentence. Last year, Fitzpatrick successfully commissioned a GAO investigation into FDA’s approval of this device and the failure of the reporting system to catch this unsafe device. [Emphasis added.]”

To further underscore the importance of this work, I’m including a quote from a petition currently circulating. The petition will be delivered to Medical Device Safety, U.S. Food and Drug Administration once it has the required number of signatures. Petitions such as this one, along with letters/emails/phone calls to your representatives, all help get across the point that women are needlessly suffering due to devices that never should have been on the market. These efforts further showcase and support the call for reform of the FDA’s device approval process, which is seriously broken.

Lynne Melby, image courtesy of www.change.org.
Lynne Melby, image courtesy of www.change.org.

In the words of Lynne Melby, author of the petition:

“As my symptoms continued to worsen, I had to leave my job and am now almost 100% reliant on my husband to care for me. I cannot drive, dress, or bathe myself without his help. I did some research and found there have been approximately 26 deaths and 10,000 complaints to the FDA regarding Essure. While the FDA told Bayer to conduct a post-market study to gather more data, the company came back claiming the benefits outweigh the risks.”[Emphasis in the original.]

Sign the petition, call/email/writer your representatives and show your support for Reps. Fitzpatrick and Slaughter as they stand for injured women in DC this Wednesday.

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